GREENSBORO, N.C.--(EON: Enhanced Online News)--Merz North America (U.S. affiliate of Merz Pharma Group) today announced the internal promotions of several individuals on its North American Leadership Team.
Bhushan Hardas, MD, MBA has been appointed to the position of Chief Scientific Officer (CSO) for Merz in North America, effective immediately. Dr. Hardas joined Merz in 2004 as Vice President, Medical and Regulatory Affairs, and has served as Vice President and US Head of Research and Development and Head of Global Research and Development – Dermatology since 2011. In his role as Chief Scientific Officer – North America, Dr. Hardas is responsible for all medical, regulatory and quality functions for Merz in North America. Dr. Hardas leads the planning and execution of all clinical and pre-clinical development programs in North America and serves as the Global lead on all of Merz‘s research and development activities relating to dermatology.
“Since joining Merz, Bhushan has continually proved himself capable of driving and supporting accelerated growth. Under his diligent leadership, our efforts in research and development have produced an impressive pipeline that touches all areas of our business. As Merz continues to provide innovative, high-quality medical products to patients and physicians in aesthetics, dermatology and neurosciences, we are confident that Bhushan’s scientific and clinical expertise will remain key to our ongoing success in North America,“ said Bill Humphries, president & CEO of Merz North America.
Dr. Hardas brings 22 years of experience to the role of Chief Scientific Officer, including 18 years focused on the clinical and pre-clinical development of dermatology products in North America and Europe. Prior to joining Merz, Dr. Hardas served as Director, Dermatology at Procyon Biopharma, Inc., a Montreal-based biotechnology company. There, he led all scientific, medical and clinical activities in support of the company's dermatology business. Prior to that time, Dr. Hardas spent eight years at Derm Cosmetic Labs, advancing to the position of Executive Director, Research and Development. Dr. Hardas received advanced training in clinical immunology and molecular biology at King's College at the University of London, in London, England. He also completed a research fellowship in the Department of Dermatology at the University of Michigan, and received his Master of Business Administration degree in healthcare management from the University of California - Irvine. Dr. Hardas is based in Merz’s North American headquarters in Greensboro, North Carolina.
In addition, Glenn Block has been appointed to the role of Vice President and U.S. Head of Neurosciences for Merz in North America, effective October 10, 2013. “Merz‘s U.S. Neurosciences division has experienced significant growth over the past year, and we anticipate that Glenn’s considerable experience in the neurotoxin market and his strong relationships with Merz Global colleagues will prove critical to our successful pursuit of additional indications for Xeomin® therapeutic in the U.S.,“ said Bill Humphries, president and CEO of Merz North America.
Block joined Merz in August 2007 and has served as President and General Manager of Merz Pharma Canada, Ltd. since August 2008. During that time, he was responsible for all aspects of the company’s strategy and operations in Canada. Block also holds the distinction of having built the Canadian organization from the ground up, including his work with Merz’s Global Commercial Operations to evaluate the Canadian market for the initial launch of Xeomin® therapeutic and to create the Canadian operations model. From August 2007 to August 2008, Block served as Merz’s Interim Brand Director for Bocouture®, driving development of Merz’s global neurotoxin product strategy until the Health Canada approval of Xeomin® therapeutic. Prior to joining Merz, Block held senior-level marketing positions with Biogen Idec Canada and Allergan, Inc. He holds an Honors Bachelor of Commerce degree from Queen’s University in Kingston, Ontario. Block will be based in Merz’s North American headquarters in Greensboro, NC.
In conjunction with Glenn Block’s transition to head of U.S. Neurosciences, Bob Bennett has been appointed to the position of President and General Manager – Merz Pharma Canada, Ltd., effective October 10, 2013. Bennett joined Merz in September 2008 as Director of Marketing and Sales, Canada and most recently served as Business Unit Director – Aesthetics/OTC.
“Bob has worked tirelessly to establish a strong presence for Merz in Canada, assisting the Canadian organization in reaching profitability after only four fiscal years of existence. Bob has already made substantial contributions to the success of Merz in North America, and we are confident in his abilities to continue to drive growth and expand our presence in the Canadian market across all the therapeutic areas that we serve there,“ said Bill Humprhies, president and CEO of Merz North America.
Bennett brings 25 years of experience to his new role as head of Merz’s Canadian business. Bennett will join Merz’s North American Leadership team and will continue to be based in Merz offices in Toronto.
About Merz North America
Merz North America is a specialty healthcare company that develops and commercializes innovative treatment solutions in aesthetics, dermatology and neurosciences in the U.S. and Canada. Our ambition is to become a recognized leader in the treatment of movement disorders, and in aesthetics and dermatology. Our future is promising, and we are committed to advancing new therapeutic options and improving patients’ lives. For more than 100 years, the development of Merz products has been based on our commitment to providing innovative medical approaches that earn trust of patients, physicians and partners worldwide. Globally, the companies of Merz Pharma Group are focused on medications for treating neurological and psychiatric illnesses, and they have assumed a leading role in the field of Alzheimer’s disease research. Founded in 1908, Merz Pharma Group is a privately owned company headquartered in Frankfurt, Germany.
For more information about Merz or the Company’s products, please visit www.merzusa.com.
IMPORTANT SAFETY INFORMATION for XEOMIN®, INCLUDING BOXED WARNING
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of XEOMIN®(incobotulinumtoxinA) for injection, for intramuscular use, and all botulinum
toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia,
generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties.
These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have
been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults
treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these
symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported
at doses comparable to those used to treat cervical dystonia and at lower doses.
Please see Full Prescribing Information, including Medication Guide for more information.
XEOMIN® is contraindicated in patients with a known hypersensitivity to the active substance botulinum toxin type A or to any of the components in the formulation and in the presence of infection at the proposed injection site(s), as injection could lead to severe local or disseminated infection.
WARNINGS AND PRECAUTIONS
- The potency units of XEOMIN® are not interchangeable with other preparations of botulinum toxin products. Therefore, units of biological activity of XEOMIN® cannot be compared to or converted into units of any other botulinum toxin products.
- Hypersensitivity reactions have been reported with botulinum toxin products (anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea). If serious and/or immediate hypersensitivity reactions occur further injection of XEOMIN® should be discontinued and appropriate medical therapy immediately instituted. Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech, or respiratory disorders.
- Treatment with XEOMIN® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. When distant effects occur, additional respiratory muscles may be involved Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months, which may require use of a feeding tube. Aspiration may result from severe dysphagiaThese reactions can occur within hours to weeks after injection with botulinum toxin. [See Boxed Warning].
- Cervical Dystonia: Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk of dysphagia. Limiting the dose injected into the sternocleidomastoid muscle may decrease the occurrence of dysphagia.
- Blepharospasm: Injection of XEOMIN® into the orbicularis oculi muscle may lead to reduced blinking and corneal exposure with possible ulceration or perforation. Lower lid injections should not be repeated if diplopia occurred with previous botulinum toxin injections.
Glabellar Lines: Do not exceed the recommended dosage and
frequency of administration of XEOMIN®. In order to reduce
the complication of ptosis the following steps should be taken:
- Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes.
- Corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.
- Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of XEOMIN®.
- XEOMIN® contains albumin. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and Creutzfeldt-Jakob disease (CJD). No cases of transmission of viral diseases or CJD have ever been reported for albumin.
Cervical Dystonia: The most commonly observed adverse reactions (incidence ≥10% of patients and twice the rate of placebo) for XEOMIN® 120 Units and XEOMIN® 240 Units, respectively, were: dysphagia (13%, 18%), neck pain (7%, 15%), muscle weakness (7%, 11%), and musculoskeletal pain (7%, 4%).
Blepharospasm: The most common adverse reactions (incidence ≥10% of patients and twice the rate of placebo) for XEOMIN® were eyelid ptosis (19%), dry mouth (16%), visual impairment (12%), diarrhea (8%), and headache (7%).
Glabellar Lines: The most common adverse reaction (incidence ≥ 2% of patients and greater than placebo) for XEOMIN® was Headache (5.4%).
Concomitant treatment of XEOMIN® and aminoglycoside antibiotics, spectinomycin, or other agents that interfere with neuromuscular transmission (e.g., tubocurarine-like agents), or muscle relaxants, should be observed closely because the effect of XEOMIN may be potentiated.
The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.
USE IN PREGNANCY
Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. XEOMIN® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The safety and effectiveness of XEOMIN® in patients less than 18 years of age have not been established.
Please see Full Prescribing Information for more information on XEOMIN® (incobotulinumtoxinA) for injection, for intramuscular use, including complete Boxed WARNING, available at www.Xeomin.com and at www.XeominAesthetic.com.
Botox® is a registered trademark of Allergan, Inc.